Conducting high-quality, culturally-appropriate primary healthcare research with Aboriginal and Torres Strait Islander peoples

Health research should inform culturally-appropriate, evidence-based primary healthcare (PHC), potentially enhancing social and emotional wellbeing (SEWB) among Aboriginal and Torres Strait Islander (hereafter referred to as Indigenous) Peoples. When conducting such research, scientific and ethical quality should be forefront. Aim To identify approaches and enablers to conducting high-quality, culturally-appropriate Indigenous-focused SEWB PHC research. Methods This thesis comprises three sections: firstly, two systematic reviews of the Indigenous-focused SEWB PHC research literature; secondly, an in-depth critical and reflective case study of an Indigenous-focused SEWB PHC research project entitled Getting it Right: the validation study (hereafter referred to as Getting it Right); finally, a process evaluation of Getting it Right using a grounded theory approach. Results Twenty-five research projects were included in the systematic reviews. Two were judged as high quality using scientific and ethical criteria. Research projects that were judged as ethical used culturally-sensitive approaches, focused on developing relationships and involved community members. These approaches also appeared to enable this research. Getting it Right had an adaptive protocol (where localised approaches were developed within certain requirements) and PHC services were reimbursed on a per participant basis. The research was evaluated as meeting scientific and ethical quality criteria. The process evaluation showed that the research was acceptable to most participating staff (n=36), community members (n=4) and participants (n=500). Many were willing to participate in research and speak about SEWB. Staff reported that the reimbursement provided to the service sufficiently resourced the research. Conclusion High-quality, culturally-appropriate Indigenous-focused SEWB PHC research can be facilitated by culturally-sensitive, flexible, collaborative and sufficiently-funded approaches

The conduct of Australian Indigenous primary health care research focusing on social and emotional wellbeing: a systematic review

Objectives and importance of study: Values and ethics: guidelines for ethical conduct in Aboriginal and Torres Strait Islander health research (Values and ethics) describes key values that should underpin Aboriginal and Torres Strait Islander (Indigenous)-focused health research. It is unclear how research teams address this document in primary health care research. We systematically review the primary health care literature focusing on Indigenous social and emotional wellbeing (SEWB) to identify how Values and ethics and community preferences for standards of behaviour (local protocols) are addressed during research. Systematic review in accordance with PRISMA Guidelines and MOOSE Guidelines for Meta-Analyses and Systematic Reviews of Observational Studies. We searched four databases and one Indigenous-specific website for qualitative, quantitative and mixed-method studies published since Values and ethics was implemented (2003). Included studies were conducted in primary health care services, focused on Indigenous SEWB and were conducted by research teams. Using standard data extraction forms, we identified actions taken (reported by authors or identified by us) relating to Values and ethics and local protocols. A total of 25 studies were included. Authors of two studies explicitly mentioned the Values and ethics document, but neither reported how their actions related to the document's values. In more than half the studies, we identified at least three actions relating to the values. Some actions related to multiple values, including use of culturally sensitive research processes and involving Indigenous representatives in the research team. Local protocols were rarely reported. Addressing Values and ethics appears to improve research projects. The academic community should focus on culturally sensitive research processes, relationship building and developing the Indigenous research workforce, to facilitate acceptable research that affects health outcomes. For Values and ethics to achieve its full impact and to improve learning between research teams, authors should be encouraged to report how the principles are addressed during research, including barriers and enablers that are encountered

The quality of Australian Indigenous primary health care research focusing on social and emotional wellbeing: a systematic review

Objectives and importance of the study: Primary health care research focused on Aboriginal and Torres Strait Islander (Indigenous) people is needed to ensure that key frontline services provide evidence based and culturally appropriate care. We systematically reviewed the published primary health care literature to identify research designs, processes and outcomes, and assess the scientific quality of research focused on social and emotional wellbeing. This will inform future research to improve evidence based, culturally appropriate primary health care. Systematic review in accordance with PRISMA and MOOSE guidelines. Four databases and one Indigenous-specific project website were searched for qualitative, quantitative and mixed-method published research. Studies that were conducted in primary health care services and focused on the social and emotional wellbeing of Indigenous people were included. Scientific quality was assessed using risk-of-bias assessment tools that were modified to meet our aims. We assessed community acceptance by identifying the involvement of community governance structures and representation during research development, conduct and reporting. Data were extracted using standard forms developed for this review. We included 32 articles, which reported on 25 studies. Qualitative and mixed methods were used in 18 studies. Twelve articles were judged as high or unclear risk of bias, four as moderate and five as low risk of bias. Another four studies were not able to be assessed as they did not align with the risk-of-bias tools. Of the five articles judged as low risk of bias, two also had high community acceptance and both of these were qualitative. One used a phenomenological approach and the other combined participatory action research with a social-ecological perspective and incorporated 'two-way learning' principles. Of the 16 studies where a primary outcome was identified, eight aimed to identify perceptions or experiences. The remaining studies assessed resources, or evaluated services, interventions, programs or policies. We were unable to identify primary outcomes in eight studies. Conducting Indigenous-focused primary health care research that is scientifically robust, culturally appropriate and produces community-level outcomes is challenging. We suggest that research teams use participatory, culturally sensitive approaches and collaborate closely to plan and implement high-quality research that incorporates local perspectives. Research should result in beneficial outcomes for the communities involved

Process evaluation of a primary healthcare validation study of a culturally adapted depression screening tool for use by Aboriginal and Torres Strait Islander people: study protocol

Process evaluations are conducted alongside research projects to identify the context, impact and consequences of research, determine whether it was conducted per protocol and to understand how, why and for whom an intervention is effective. We present a process evaluation protocol for the Getting it Right research project, which aims to determine validity of a culturally adapted depression screening tool for use by Aboriginal and Torres Strait Islander people. In this process evaluation, we aim to: (1) explore the context, impact and consequences of conducting Getting It Right, (2) explore primary healthcare staff and community representatives' experiences with the research project, (3) determine if it was conducted per protocol and (4) explore experiences with the depression screening tool, including perceptions about how it could be implemented into practice (if found to be valid). We also describe the partnerships established to conduct this process evaluation and how the national Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research is met. Realist and grounded theory approaches are used. Qualitative data include semistructured interviews with primary healthcare staff and community representatives involved with Getting it Right. Iterative data collection and analysis will inform a coding framework. Interviews will continue until saturation of themes is reached, or all participants are considered. Data will be triangulated against administrative data and patient feedback. An Aboriginal and Torres Strait Islander Advisory Group guides this research. Researchers will be blinded from validation data outcomes for as long as is feasible. The University of Sydney Human Research Ethics Committee, Aboriginal Health and Medical Research Council of New South Wales and six state ethics committees have approved this research. Findings will be submitted to academic journals and presented at conferences. ACTRN12614000705684. [Abstract copyright: © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Getting it Right: study protocol to determine the diagnostic accuracy of a culturally-specific measure to screen for depression in Aboriginal and/or Torres Strait Islander people

Abstract Introduction: A freely available, culturally valid depression screening tool is required for use by primary care services across Australia to screen for depression in Aboriginal and/or Torres Strait Islander populations. This is the protocol for a study aiming to determine the validity, sensitivity and specificity of the culturally adapted 9-item Patient Health Questionnaire (aPHQ-9). Methods and analysis: Cross sectional validation study. A total of 500 people who self-identify as Aboriginal and/or Torres Strait Islander, are ≥ 18 years of age, attending one of 10 primary health care services or service events across Australia and able to communicate sufficiently to answer study questions will be recruited. All participants will complete the aPHQ-9 and the criterion standard MINI International Neuropsychiatric Interview (MINI) 6.0.0. The primary outcome is criterion validity of the aPHQ-9. Process outcomes related to acceptability and feasibility of the aPHQ-9 will be analysed only if the measure is found to be valid. Ethics and dissemination: Lead ethical approval was obtained jointly from the University of Sydney Human Research Ethics Committee (project 2014/361) and the Aboriginal Health and Medical Research Council of New South Wales (project 1044/14). Results will be disseminated via the usual scientific forums including peer-reviewed publications and presentations at international conferences following presentation to, discussion with and approval by participating primary health care service staff and community. Study registration number: ACTRN1261400070568

Getting it Right: validating a culturally specific screening tool for depression (aPHQ‐9) in Aboriginal and Torres Strait Islander Australians

Objectives To determine the validity, sensitivity, specificity and acceptability of the culturally adapted nine‐item Patient Health Questionnaire (aPHQ‐9) as a screening tool for depression in Aboriginal and Torres Strait Islander people. Design Prospective observational validation study, 25 March 2015 – 2 November 2016. Setting, participants 500 adults (18 years or older) who identified as Aboriginal or Torres Strait Islander people and attended one of ten primary health care services or service events in urban, rural and remote Australia that predominantly serve Indigenous Australians, and were able to communicate sufficiently to respond to questionnaire and interview questions. Main outcome measures Criterion validity of the aPHQ‐9, with the depression module of the Mini‐International Neuropsychiatric Interview (MINI) 6.0.0 as the criterion standard. Results 108 of 500 participants (22%; 95% CI, 18–25%) had a current episode of major depression according to the MINI criterion. The sensitivity of the aPHQ‐9 algorithm for diagnosing a current major depressive episode was 54% (95% CI, 40–68%), its specificity was 91% (95% CI, 88–94%), with a positive predictive value of 64%. For screening for a current major depressive episode, the area under the receiver operator characteristic curve was 0.88 (95% CI, 0.85–0.92); with a cut‐point of 10 points its sensitivity was 84% (95% CI, 74–91%) and its specificity 77% (95% CI, 71–83%). The aPHQ‐9 was deemed acceptable by more than 80% of participants. Conclusions Indigenous Australians found the aPHQ‐9 acceptable as a screening tool for depression. Applying a cut‐point of 10 points, the performance characteristics of the aPHQ were good

Process evaluation of the Getting it Right study and acceptability and feasibility of screening for depression with the aPHQ-9

The Getting it Right study determined the validity, sensitivity, specificity and acceptability of the culturally adapted 9-item Patient Health Questionnaire (aPHQ-9) as a screening tool for depression in Aboriginal and Torres Strait Islander (hereafter referred to as Indigenous) people. In this process evaluation we aimed to explore staff perceptions about whether Getting it Right was conducted per protocol, and if the aPHQ-9 was considered an acceptable and feasible screening tool for depression in primary healthcare. This process evaluation will provide information for clinicians and policy makers about the experiences of staff and patients with Getting it Right and what they thought about using the aPHQ-9. Process evaluation using grounded theory approaches. Semi-structured interviews with primary healthcare staff from services participating in Getting it Right were triangulated with feedback (free-text and elicited) from participants collected during the validation study and field notes. Data were thematically analysed according to the Getting it Right study protocol to identify the acceptability and feasibility of the aPHQ-9. Primary healthcare staff (n = 36) and community members (n = 4) from nine of the ten participating Getting it Right services and Indigenous participants (n = 500) from the ten services that took part. Most staff reported that the research was conducted according to the study protocol. Staff from two services reported sometimes recruiting opportunistically (rather than recruiting consecutive patients attending the service as outlined in the main study protocol), when they spoke to patients who they knew from previous interactions, because they perceived their previous relationship may increase the likelihood of patients participating. All Getting it Right participants responded to at least six of the seven feedback questions and 20% provided free-text feedback. Most staff said they would use the aPHQ-9 and most participants said that the questions were easy to understand (87%), the response categories made sense (89%) and that they felt comfortable answering the questions (91%). Getting it Right was predominantly conducted according to the study protocol. The aPHQ-9, the first culturally adapted, nationally validated, freely available depression screening tool for use by Indigenous people, appears to be acceptable and feasible to use. Australian New Zealand Clinical Trial Registry ANZCTR12614000705684 , 03/07/2014

'We're here to listen and help them as well': a qualitative study of staff and Indigenous patient perceptions about participating in social and emotional wellbeing research at primary healthcare services

Research can inform culturally-appropriate care to strengthen social and emotional wellbeing (SEWB) among Aboriginal and Torres Strait Islander (hereafter, the term 'Indigenous Peoples' is respectfully used and refers to all Aboriginal and/or Torres Strait Islander Peoples of Australia). We acknowledge the cultural diversity of Australia's Indigenous First Peoples and they do not represent a homogenous group.) (hereafter Indigenous) Peoples. We explore the perspectives of primary healthcare staff and Indigenous patients about their willingness to and experiences participating in SEWB research. Process evaluation using grounded theory approaches of Getting it Right: The validation study, a national validation designed Indigenous SEWB research project (N = 500). Primary healthcare staff (n = 36) and community members (n = 4) from nine of ten primary healthcare services involved with the research project completed qualitative semi-structured interviews. Interview data were triangulated with participant feedback (responses to structured questions and free-text feedback collected during Getting it Right), study administrative data (participant screening logs, communication logs, study protocol, deviation logs and ethics correspondence) and interviewer field notes. Three themes about staff, patient and community perspectives concerning research participation developed: (1) considering the needs, risk, preferences and impact of participation in research for staff, patients and community; (2) building staff confidence speaking to patients about research and SEWB problems and (3) patients speaking openly about their SEWB. Some staff described pressure to ensure patients had a positive experience with the research, to respond appropriately if patients became upset or SEWB problems were identified during interviews, or due to their dual role as community member and researcher. Patients and staff reported that patients were more likely to participate if they knew the staff outside of the service, especially staff with a shared cultural background, and they perceived SEWB as a community priority. Staff reported their skills speaking to patients about the research and SEWB improved during the research, which built their confidence. Contrary to staff preconceptions, staff and patients reported that many patients appreciated the opportunity to speak about their SEWB and contributing to research that may eventually enhance SEWB in their community. Our research project was considered acceptable by most staff and patients. The positive outcomes reported by staff and feedback from patients highlights the importance of providing opportunities for people to speak about their SEWB and for research-informed SEWB PHC care. Getting it Right is registered on ANZCTR12614000705684

Antiepileptic drugs’ tolerability and safety – a systematic review and meta-analysis of adverse effects in dogs

<p>Various anti-epileptic drugs (AEDs) are used for the management of idiopathic epilepsy (IE) in dogs. Their safety profile is an important consideration for regulatory bodies, owners and prescribing clinicians. However, information on their adverse effects still remains limited with most of it derived from non-blinded non-randomized uncontrolled trials and case reports.</p><p><span>This poster won third place, which was presented at the Veterinary Evidence Today conference, Edinburgh November 1-3, 2016. </span></p><br /> <img src="https://www.veterinaryevidence.org/rcvskmod/icons/oa-icon.jpg" alt="Open Access" /

A Cluster-Randomised Stepped-Wedge Impact Evaluation of a Pragmatic Implementation Process for Improving the Cultural Responsiveness of Non-Aboriginal Alcohol and Other Drug Treatment Services: A Pilot Study

There is limited evidence regarding implementing organisational improvements in the cultural responsiveness of non-Aboriginal services. Using a pragmatic implementation process to promote organisational change around cultural responsiveness, we aimed to (i) identify its impact on the cultural responsiveness of participating services; (ii) identify areas with the most improvement; and (iii) present a program logic to guide cultural responsiveness. A best-evidence guideline for culturally responsive service delivery in non-Aboriginal Alcohol and other Drug (AoD) treatment services was co-designed. Services were grouped geographically and randomised to start dates using a stepped wedge design, then baseline audits were completed (operationalization of the guideline). After receiving feedback, the services attended guideline implementation workshops and selected three key action areas; they then completed follow-up audits. A two-sample Wilcoxon rank-sum (Mann&ndash;Whitney) test was used to analyse differences between baseline and follow-up audits on three key action areas and all other action areas. Improvements occurred across guideline themes, with significant increases between median baseline and follow-up audit scores on three key action areas (median increase = 2.0; Interquartile Range (IQR) = 1.0&ndash;3.0) and all other action areas (median increase = 7.5; IQR = 5.0&ndash;11.0). All services completing the implementation process had increased audit scores, reflecting improved cultural responsiveness. The implementation process appeared to be feasible for improving culturally responsive practice in AoD services and may be applicable elsewhere